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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study reported in peer-reviewed journal article.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Version / remarks:
HGPRT point mutation
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
Alkylate 225
IUPAC Name:
Alkylate 225
Constituent 2
Reference substance name:
Benzene, C10 -16 alkyl derivs.
IUPAC Name:
Benzene, C10 -16 alkyl derivs.
Details on test material:
- Composition of test material, percentage of components: <1% C9, 11% C10, 27% C11, 51% C12, 11% C13, 1% C14; average C11.84
- Analytical purity: 98.5%

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
S9 from aroclor 1254 induced rat liver
Test concentrations with justification for top dose:
100-2000 microliter/mL
Vehicle / solvent:
ethanol
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: ethylmethanesulfonate, benzo(a)pyrene, dimethylnitrosamine
Evaluation criteria:
A response was considered positive if one of the three highest concentrations with survival of at least 10% had a mean mutation frequency significantly greater than that of controls, and if there was a dose-response relationship.
Statistics:
Student's t-test was used to compare mutation frequency. Dose-response was analyzed using one-way analysis of variance.

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
0.5 mg/mL both with and without activation
Additional information on results:
No significant increase in mutation frequency was seen in the treatment groups.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Mutagenicity

Concentration

Mutagenicity

(mutation frequency x 10-6)

Without S9

100

2.2

150

-

250

-

500

2.3

750

-

1000

3.0

1100

13.2

1250

1.1

1500

1.6

1750

-

2000

-

Solvent control

3.5

Ethyl methanesulfonate

237.9

5% S9

100

0.4

500

0.8

1000

8.1

1250

3.7

1500

0.8

1750

-

2000

-

Solvent control

4.3

DMN

202.8

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Negative for mutagenicity in CHO/HGPRT assay.
Executive summary:

This study examined the potential of the test substance to cause mutations in mammalian cells. Chinese hamster ovary cells were exposed to concentrations of 100-2000 microliter/mL of test substance both in the presence and absence of metabolic activation. Ethanol was used as a vehicle. Ethylmethanesulfonate, benzo(a)pyrene, and dimethylnitrosamine were used as positive controls. Cytotoxicity was seen at concentrations of 0.5 mg/mL and above both with and without metabolic activation. No significant increase in mutation frequencies was seen in treatment groups. The test substance is not mutagenic to mammalian cells.

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